Sulodexide for the Prevention of Recurrent Venous Thromboembolism: The Sulodexide in Secondary Prevention of Recurrent Deep Vein Thrombosis (SURVET) Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Sulodexide for the Prevention of Recurrent Venous Thromboembolism: The Sulodexide in Secondary Prevention of Recurrent Deep Vein Thrombosis (SURVET) Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
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DOI：
10.1161/circulationaha.115.016930
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发表时间：
2015-11-17
期刊：
影响因子：
37.8
通讯作者：
SURVET Study Investigators
中科院分区：
文献类型：
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作者：
Andreozzi GM;Bignamini AA;Davì G;Palareti G;Matuška J;Holý M;Pawlaczyk-Gabriel K;Džupina A;Sokurenko GY;Didenko YP;Andrei LD;Lessiani G;Visonà A;SURVET Study Investigators
补充数字内容可在文本中找到。首次发生无因性静脉血栓栓塞的患者在停止抗凝治疗后复发的风险很高。延长抗凝治疗可降低复发风险，但与出血增加有关。舒洛地特是一种糖胺聚糖，口服时具有抗血栓和纤原蛋白溶解作用，出血风险低，但其预防静脉血栓栓塞复发的益处尚不清楚。在这项多中心双盲研究中，615例首次非诱发性静脉血栓栓塞患者完成了3至12个月的口服抗凝治疗，随机分配到每天两次的500脂凝单位舒洛地特或安慰剂组，为期2年，此外还有弹力袜。主要疗效指标为静脉血栓栓塞复发。主要的或临床相关的出血是主要的安全结局。307例接受舒洛地特治疗的患者中有15例静脉血栓栓塞复发，308例接受安慰剂治疗的患者中有30例静脉血栓栓塞复发（风险比为0.49；95%可信区间[CI]， 0.27-0.92； P=0.02）。在随访失败的分析中，治疗组与对照组的风险比为0.54（95%可信区间，0.35-0.85；P=0.009）。未发生大出血；两组均有2例患者出现与临床相关的出血事件。两组不良事件相似。停用抗凝治疗后给予舒洛地特可降低非诱发性静脉血栓栓塞患者的复发风险，且出血风险无明显增加。URL: https://www.clinicaltrialsregister.eu/。标识：草案编号2009-016923-77。
Supplemental Digital Content is available in the text. Patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after discontinuation of anticoagulant therapy. Extending anticoagulation reduces the risk of recurrence but is associated with increased bleeding. Sulodexide, a glycosaminoglycan, exerts antithrombotic and profibrinolytic actions with a low bleeding risk when administered orally, but its benefit for preventing recurrent venous thromboembolism is not well known. In this multicenter, double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3 to 12 months of oral anticoagulant treatment were randomly assigned to sulodexide 500 lipasemic units twice daily or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome. Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27–0.92; P=0.02). The analysis in which lost to follow-up was assigned to failure yielded a risk ratio among treated versus control subjects of 0.54 (95% confidence interval, 0.35–0.85; P=0.009). No major bleeding episodes occurred; 2 patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the 2 groups. Sulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk. URL: https://www.clinicaltrialsregister.eu/. Identifier: EudraCT number 2009-016923-77.